Device product
cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
Z-0109-2017
Product summary
- Event
- Event 75186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9014 in total
- Official record key
device-enforcement:Z-0109-2017
Official wording
Reason: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Code information: Not applicable
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.